Preparing for ISO 9000.

Introduction

This checklist is for managers involved with the implementation of a Quality Management System (QMS) within their organisation, based on ISO 9000, and describes the processes involved.

Most quality initiatives are aimed at increasing customer satisfaction and involve many elements in the process, such as training, "getting it right first time", empowerment, performance measurement, continuous improvement and managing change.

The ISO 9000 series of standards provides a model with which organisations can build a QMS to create cohesion and integration of a group of initiatives that might otherwise be approached in isolation from each other. Having developed a system based on ISO 9000, it is then possible to obtain registration through a nationally recognised accreditation body.

ISO 9000 presents an opportunity for fully integrating organisational improvement which improves and simplifies processes by examining what you do and how you do it, providing an increased awareness of customers' needs and expectations.

National Occupational Standards for Management and Leadership

This checklist has relevance for the following standards: B: Providing direction, unit 8.

Definition

ISO 9000 provides a framework for an organisation to develop a QMS to suit its own individual situation regardless of the end product, be it tangible (manufactured) intangible (service) or a combination of both. It provides guidelines for good management practice that identify the basic disciplines, specifying the criteria by which processes can be examined to ensure that products or services meet customers' expectations. The standard also gives a guide to measuring the effectiveness of the QMS and making use of those measures to continually improve both products and services.

Action checklist

1. Buy and read the standard and relevant guidelines

The ISO 9000 series of standards outline the requirements for a QMS. ISO 9000 defines the terms and vocabulary used; ISO 9001 gives the full specification for a QMS, and ISO 9004 outlines the continual improvement process.

The standard allows organisations to tailor some of the requirements to suit their circumstances. They are allowed to omit parts of the Product Realisation section if it is not appropriate to the organisation or the product or service, or is not required by customers. All other sections of the standard are mandatory. Any reason for exclusion must be clearly defined and qualified within the Quality Manual.

2. Gain top management commitment

The standard places responsibility on senior management to manage the QMS. They must understand their customers' needs at a strategic level and be able to translate this into policies and objectives to meet these needs. They must also make sure that there are clear paths of communication throughout the organisation, and that all staff are aware of customers' needs. There is a requirement for senior management to regularly review the effectiveness of the QMS system.

3. Decide how the organisation will be registered and select an assessment body

It is possible for just part of the organisation to apply for registration. If there is just a single site, then consider if all departments are to be accredited; if multi-site, then all sites must apply individually. Be careful to adopt a unified approach across the organisation, working within the guidelines of ISO 9000. It is better for diverse sites to work together to register, irrespective of the end product.

One of the first tasks will be to select an assessment body even though registration is at the end of the process. The United Kingdom Accreditation Service (UKAS) provides information on suitable accreditation bodies for specific industry sectors. It is advisable to select an accreditation body approved by UKAS, and to have the development process and the accreditation assessment carried out by separate bodies, rather than by the same one.

4. Appoint a management representative

The management representative will be a member of the organisation's management who is given the overall day-to-day responsibility for the administration of the QMS. The appointee must be a member of the organisation's own staff and not an outside consultant. He or she also provides the link with the assessment body both during and between assessment visits.

5. Decide if outside help is required

Depending on the resources and knowledge available within your organisation you may wish to employ outside help. Some trade organisations are able to provide assistance in this matter. There are also many organisations providing training courses in ISO 9000 and quality management techniques. Employing outside help will add to the cost of registration but that must be balanced with the benefits and expertise provided.

6. Involve staff

It is vital to gain the commitment of all staff. Some staff may see the standard as bureaucratic, or as a threat to their working practices or as drawing attention to individuals when a mistake is made. It is important to allay any such fears and to emphasise that the aim is to improve the quality of the end product or service through a simplification and rationalisation of processes, and that every member of staff has an important contribution to make.

7. Interpret the requirements

There are eight sections in ISO 9001, each with a number of sub-sections. The first three are for definition only, the remaining five are operational.

          Section              Comment

4. Quality Management System   The foundation of a QMS. Looks at
                               processes and their interaction, and
                               specifies the documentation needed to
                               effectively manage the system.

5. Management Responsibility   How top management will manage the
                               system.

6. Resource Management         How the organisation's resources are
                               utilised to carry out the processes.

7. Product Realisation         This section is concerned with how
                               input is converted into output

8. Measurement, Analysis,      How an organisation measures the
   Improvement                 performance of the QMS and how these
                               measures are used for continual
                               improvement.

8. Write a quality policy

A quality policy is the foundation upon which all quality activities are based. It is a mission statement and it must originate from senior management. The quality policy should be kept simple, to enable it to be understood by all staff whilst confirming the requirement of the standard, its objectives and goals for quality, including the requirement to meet customer expectations and needs.

9. Draw up a quality plan

A quality plan is a useful tool on which to timetable, build and chart progress, allocate resources and define responsibilities for action. During the process, all involved should meet and review progress at regular intervals to enable the impetus to be maintained. Care must be exercised in providing a realistic timetable.

10. Document the QMS

Having decided how you are to implement the standard, the next step is to map the system. ISO 9001 requires a quality manual and operational procedures to be written. The manual should show the interaction of processes within the organisation, and mapping them provides a key to understanding the organisational flow and ultimately where improvements can be made. One method is to graphically represent processes using some form of flowchart, clearly showing the relationships and flow of work. Remember that any process will have three stages--input, operation and output.

ISO 9001 allows you to record the QMS in any medium you choose providing there is clear evidence of control to prevent unauthorised changes. Whilst developing the QMS, take into account existing systems, how they contribute to the aims of your QMS, and the competency of staff involved in carrying out the processes.

11. Establish performance indicators

A framework must be established to measure the effectiveness of the QMS. Select realistic and measurable indicators, such as the length of time taken to answer a customer query, output rates and reject quantities. Define how indicators are to be measured and set targets to be achieved. Monitor performance against targets on a regular basis.

12. Use complaints positively

Establish or enhance your existing complaints system by treating each complaint, be it from external or internal sources, as an indicator of the need for improvement. Positive action is required to correct the fault (short-term) and prevent it happening again (longer term). Keep the complainant informed of progress.

13. Review the system

After commencing the project, allow a reasonable amount of time before reviewing the system by establishing an audit programme. A quality audit is a key review tool, and looks at what is done in relation to the standard, in terms of organisational processes and procedures. Audit non-conformities not only point out deviations from the agreed procedure but may also indicate areas for further amendment. Examine and action any trends in the number and type of nonconformities.

14. Get ready for assessment

When you are satisfied that the QMS has begun achieving the goals and objectives set in the quality policy, and when there has been sufficient time to obtain sufficient documentary records, then it is time to be assessed. Some assessment bodies offer a pre-assessment visit to enable potential discrepancies to be addressed beforehand. If this is not viable, then conduct an independent audit of the whole system. It is possible that a first audit may highlight a number of discrepancies, most probably of a minor nature, but each one having the potential to prevent successful registration. Only when you are satisfied that the QMS is performing as you and the standard require, arrange for the assessment visit.

15. Assessment

This will be exhaustive in nature, and may well last two or three days, so be prepared to devote time solely to the assessment team. Assessments start with an opening meeting where the assessors explain what they are looking for and the actions they will take if discrepancies are found.

The main body of the visit normally consists of two parts, a documentation audit and an implementation audit. In the former, the assessors will look at how the QMS addresses the requirements of the standard, and in the latter, will look for evidence to show that what has been written down is actually being practised. The visit will finish with a closing meeting where the assessors will present a report on what they have found and anything that needs to be changed or corrected. Depending on the nature and number of discrepancies found they may or may not recommend registration. Occasionally the assessors may recommend that any serious non-conformities are addressed prior to registration, in which case a second visit may be required.

16. Maintaining registration

Once you have been awarded ISO 9000 registration, it is important to maintain a constant check on the QMS by auditing and quality review meetings. An assessor from the chosen accreditation body will visit at least once a year, sometimes more, and whilst not carrying out a full assessment each time, will certainly want to see evidence of review and continuing improvement. Don't forget that a QMS is flexible, not carved in stone.

Do's and don'ts for ISO 9000 accreditation

Do

* Focus on the customer.

* Read the standard.

* Involve staff.

* Keep procedures simple.

* Maintain a constant review.

* What you say you do.

Don't

* Write all the procedures yourself.

* Let bureaucracy run amok.

* Forget to involve customers and suppliers.

* Be afraid to change anything which is not proving effective.

Standards

BS EN ISO 9000: 2000 Quality Management Systems: fundamentals and vocabulary

BS EN ISO 9001: 2000 Quality Management Systems: requirements

BS EN ISO 9004: 2000 Quality Management Systems: guidelines for performance improvement.

Available from British Standards Institution (BSI) - see below.

Additional resources

Books

ISO9001 2000 in brief, 2nd ed, Ray Tricker and Bruce Sherring-Lucas

Amsterdam: Butterworth Heinemann, 2005

Quality audit for ISO9001 2000: a practical guide, 2nd ed, David Wealleans

Aldershot: Gower, 2005

ISO9000 2000 an A to Z guide, David Hoyle

Oxford: Butterworth Heinemann, 2003

Managing quality, 4th ed, Barrie G Dale

Malden Mass: Blackwell, 2003

Gower handbook of quality management, 3rd ed, Matt Seaver ed 

Aldershot: Gower, 2003

Beyond registration: getting the best from ISO9001 and business improvement, Steve Tanner, Mike Bailey and Charles Pertwee

London: European Centre for Business Excellence, 2003

Customer satisfaction measurement for ISO9000:2000, Nigel Hill, Bill Self and Greg Roche

Oxford: Butterworth Heinemann, 2002

This is a selection of books available for loan to members from the Management Information Centre. More information at: www.managers.org.uk/mic

Internet resources

British Standards Institution (BSI)

An overview and explanation of ISO 9000

http://emea.bsi-global.com/Quality/Overview/WhatisISO9000.xalter

Organisations

British Standards Institution (BSI)

389 Chiswick High Rd, London, W4 4AL

Tel: [phone] e-mail: [e-mail]

Web: www.bsi-global.com

United Kingdom Accreditation Service (UKAS)

21-47 High Street, Feltham, Middlesex, TW13 4UN

Tel: [phone] e-mail: [e-mail]

Web: www.ukas.com

Institute of Quality Assurance

12 Grosvenor Crescent 

London SW1X 7EE

Tel: [phone] e-mail: [e-mail]

Web: www.iqa.org

International Organisation for Standards

International Organization for Standardization (ISO)

1, rue de Varembe, Case postale 56

CH-1211 Geneva 20, Switzerland

Tel [phone]; Fax [phone]

Web: www.iso.org